This invention pertains to the general field of electro-diagnostic systems and more particularly to a system which monitors muscles in various ranges of motion such as lifting, pulling, pushing, gripping and pinching while simultaneously monitoring physiological functions such as temperature, heart rate and skin response.
Many physicians encounter patients with complaints that involve injuries of the soft tissues, particularly those soft tissues of the paraspinal muscles. In many cases objective findings are obvious, but a percentage of patients have injuries that, while subtle, still cause symptoms that bring them to the attention of a care provider or specialist. In other cases, the injuries many be less recent, which provide no apparent physical findings. Direct palpation of soft tissues can, in some cases, reveal the nature or type of injury, but this manner of diagnosis relies on static testing. For some subject, problems may only be encountered during activity. Quantifying these dynamic condition of the soft tissues is problematic.
Range of motion testing is often relied upon to determine the cause, yet measuring the muscle activity during range of Motion testing is difficult. The extent to which a patient exerts him or herself also presents a subjective bias. If muscle activity could be recorded during range of motion testing, the extent to which the muscles or muscle groups are activated and to what degree would provide helpful information about the nature of the soft tissue injury.
The Mayo Clinic confirmed in their studies on sagittal gait patterns and knee joint functions that static measurements do not correlate well with true functional assessment of movement. As part of their conclusions, they recommended the use of functional assessments as a routine diagnostic tool in a similar manner as an electrocardiogram (EKG). In this setting, the use of tests like magnetic resonance imaging (MRI) or X-rays are of little use, since they are static tests and not specifically designed to evaluate soft tissue damage and the subsequent change in function. Therefore, there is a growing need within the medical, insurance and industrial communities for an objective analysis of biomechanics on a functional level.
Myofacial injuries represent a significant medical problem, with back pain accounting for a large number of medical visits. Carpal tunnel syndrome (CTS) and repetitive stress injuries (RSI) account for the most days lost and is currently one of the most costly health problems. The cost of this health problem is expected to increase because OSHA has passed a musculoskeletal disorder standard for repetitive stress injuries. With the implementation of the American""s with disability (ADA) law, worker""s compensation claims such as (CTS) can now sue in the federal court system, allowing for suits in excess of 10 million dollars. These expensive claims could damage the economy and force employers to go outside of the United States.
A recent study revealed that over 45 percent of individuals who have undergone CTS release surgery mere no better two years past the surgical intervention because they were misdiagnosed. The individuals probably had cervical pathology that can refer pain and mimic the symptoms of CTS, ulnar neuopathy, cubital tunnel, tendonititis, DeQuarian""s syndrome i.e., repetitive stress injuries. The problem is that until the development of the instant invention, there was no way to ascertain if the problem was proximal, cervical or distal.
In the past, many doctors have prescribed a profalatic work restriction limiting the amount an individual can lift. More often than not, the lifting restriction is too general and too limiting which prohibits the individual from returning back to their visual or any job. For example, a typical work restriction of not lifting over 50 pounds is highly restrictive. Doctors impose this restriction because they have no means of evaluating the muscle and disc pathology during movement.
The inventive combined physiological monitoring system (CPMS) solves many of the above problems on data gathering by combining up to 32 channels of proprietary surface EMG, up to 12 range of motion channels, two CPMS sensors and a grip strength. There is also room for at least two cables of electromyography (EMG). The CPMS also combines two channels of nerve conduction velocity (NCV) to apply a current to monitor NCV with temperature control and pre-set electrodes. The CPMS can also be designed to operate with utility power or to be battery operated to allow an individual to be monitored anywhere, including the worksite.
A search of the prior art did not disclose any patents that read directly on the claims of the instant invention. However, the following U.S. patents were considered related:
The U.S. Pat. Nos. 5,513,651 and 5,462,065 disclose an integrated movement analyzing system that utilizes surface electromyography in combination with range of motion and functional capacity testing to monitor muscle groups in the human body. The system consists of an integrated movement analyzer (IMA) that receives inputs from surface EMG electrodes, a range of motion arm (ROMA), and a functional capacity sensor. When performing Upper and lower back testing, the ROMA is connected between the patient""s upper back and lower back by a shoulder harness and a waist belt. For cervical testing, the ROMA is connected between the patient""s head and upper back by a cervical cap and the shoulder harness. The output of the IMA is provided via an analog to digital converter to a computer. The computer in combination with a software program produces an output consisting of comparative analytical data.
The U.S. Pat. No. 5,042,505 discloses an electronic device for measuring relative angular positional displacement and annular range of motion for body segments and articulating joints of the human skeleton. The device has a hand-held interface unit which is placed against the body segment or joint to be tested. Mounted within the housings of the interface unit is a shaft with a pendulum at one end and an optical encoder at the other. As the body segment rotates or the joint articulates, the pendulum swings in the direction of gravity, causing the shaft to rotate. The optical encoder generates an electrical signal representative of the amount of rotation of the shaft. The generated signal is fed to a microprocessor which processes the information and can produce on a display the change in angular position relative to initial angular position or the angular range of motion of the body segment or articulating joint.
The U.S. Pat. No. 4,688,581 discloses an apparatus and a method for non-invasive in vivo determination of muscle fiber composition. The method includes the steps of electrically stimulating a chosen muscle; determining the stimulation current; measuring the electrical potential of the muscle; the contraction timer and the force produced by the contraction; and by intercorrelating the data by multiple regression, determining the type, percentage and size of muscle fibers within the muscle stimulated. Apparatus for determining the muscle composition includes a muscle stimulator of controlled voltage electromyogram equipment, and a force transducer providing a tension curve as well as force measurements.
The U.S. Pat. No. 4,667,513 discloses an apparatus and a method for estimating the degree of the fatigue and pain of muscles. The apparatus composes subjects of different weights on the same basis by deriving the variation in the muscular strength such as dorsal muscular strength, shoulder muscular strength, grasping power and the like. An analogous electric signal integrates the muscular output on one hand, and provides an integrated value of the electromyogrammatic amplitude by processing the voltage induced from the muscle to be tested through an electromyogram amplitude and a waveform processor. The ratio between these integrated values, after correcting the ratio with a weight/muscular strength coefficient is digitally displayed.
For background purposes and as indicative of the art to which the invention relates, reference may be made to the following remaining patents found in the search:
The combined physiological monitoring system (CPMS) consist of a portable, non-loading electronic unit that simultaneously monitors muscle activity with standard electrode. The muscle groups in the human body, including cervical, midback, low back and upper and lower extremities, are monitored. The CPMS also uses the gold standard in combination with a load cell and strain gauge to determine a person""s lifting, gripping and range-of-motion capability. The CPMS functions with a dedicated computer and a proprietary software program, entitled Patient Data Acquisition System (PDAS) which correlates muscle activity with a force produced by a person. The design of the CPMS allows electromyography (EMG), range-of-motion, grip assessment and functional assessment to be conducted during a single testing session.
During an injury to a muscle and/or fascial elements, many pathophysiological processes occur which follow a predictable pattern. When a muscle is strained, the fibers of that muscle are damaged and cells within the muscle are ruptured. These ruptured cells release substances which cause the muscle to reflexively tighten. Muscles that cause an action (agonist) and muscles which prevent the action (antagonist) are monitored. Muscle groups which are distant from the injury site may not be performing their proper function since they are compensating for the loss of function due to the injury. The greater the pattern of compensation the more longstanding is the injury.
The EMG provided by the CPMS will record a signal of increased amplitude and frequency from a muscle which is characteristic of an acute injury. The process of aging an injury is multi-factorial and involves not only muscle groups, but their interrelationship with each other. An electrodiagnostic functional assessment (EFA) provided by the CPMS can monitor up to a total of 19 muscle groups simultaneously.
By understanding the natural progression of a myofascial injury, and the information provided by the CPMS, the relative age of an injury can be determined.
In its most basic form, the CPMS is comprised of the following elements, which are shown in FIG. 1 and described in the Best Mode for Carrying out the invention:
a) a plurality of EMG sensors,
b) a range-of-motion (ROM) arm,
c) a plurality of functional capacity evaluation (FCE) sensors,
d) a grip sensor,
e) a pinch sensor,
f) a power supply
g) a computer,
h) software, and
i) a CPMS control circuit.
In view of the above disclosure, the primary object of the CPMS is to monitor selective muscle activity in a human body, which includes cervical, thoraic, upper and lower extremities and lumbosacral. The CPMS can simultaneously correlate the muscle activity with EMG, range-of-motion, grip assessment and a functional assessment.
In addition to the primary object of the invention, it is also an object of the invention to produce a CPMS that:
identifies malingering persons, workers who may be magnifying symptoms, and most importantly, in diagnosing real injuries and allows the acquired data to be reviewed to determine appropriate treatment,
assesses the actual extent of myofascial injuries that might be job or accident related,
allows muscle pathology to be assessed above and below the area of the reported injury which then allows the total extent of an injury to be established to determine future treatment, the probability of permanent disability and the need for potential vocational rehabilitation,
provides a real time diagnosis of muscle activity,
provides a powerful tool for establishing an evaluation and treatment program,
can assess chronic versus acute injuries by evaluating muscle compensation,
can assist physicians who care for professional or high level college athletes, in determining the extend of sports-related musculoskeletal injuries, and provide accurate data that can be used in designing site-specific treatment protocols, thus allowing a more rapid, predicable and safe return to competition. It can also be used in pre-participation physical examinations and allow trainers to address otherwise undiagnosed deficiencies, and
can assess the clinical significance of disc pathology.
In summary, the CPMS identifies the severity of injuries allows future diagnostic and treatment programs to be established that take into account both the needs of the injured person and the need to contain the runaway costs of potential long term or unsubstantiated cases.
These and other objects and advantages of the present invention will become apparent from the subsequent detailed description of the preferred embodiment and the appended claims taken in conjunction with the accompanying drawings.